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    • HPM Issues Detailed FDAAA Summary and AnalysisOctober 11th, 2007

      Earlier today, Hyman, Phelps & McNamara, P.C. issued its detailed summary and analysis of the recently-enacted FDA Amendments Act (“FDAAA”).  A copy of the summary and analysis is available here.  FDAAA reauthorizes several user fee and pediatric-related laws, and includes a host of new provisions, …

    • FDA Announces New Generic Drug InitiativeOctober 4th, 2007

      Earlier today, FDA announced a new initiative, called the Generic Initiative for Value and Efficiency (“GIVE”), which is intended to increase the number and variety of generic drug products.  According to Gary Buehler, R.Ph., Director of FDA’s Office of Generic Drugs (“OGD”): GIVE is an initiative …

    • FDA Solicits Comments on 180-Day Exclusivity Forfeiture & Orange Book Patent “Delisting” IssuesSeptember 26th, 2007

      Earlier today, FDA’s Office of Generic Drugs posted a letter on its website requesting comment on certain 180-day exclusivity forfeiture and Orange Book patent “delisting” issues concerning at least one ANDA submitted to the Agency containing a paragraph IV patent certification requesting FDA approval for …

    • Senate Passes Omnibus FDA Reform LegislationSeptember 20th, 2007

      Late today, the U.S. Senate passed FDA reform legislation by unanimous consent.  The Senate vote follows the House’s action yesterday when it passed H.R. 3580, the FDA Amendments Act of 2007.  Earlier in the day there was some concern that the Senate vote on the …

    • An Agreement Has Been Reached – House and Senate Staff Negotiators Release “Staff Agreement” on Omnibus FDA Reform Legislation; a Vote is Expected SoonSeptember 19th, 2007

      House and Senate staff have reportedly reached an agreement on omnibus FDA reform legislation that would, among several other things, reauthorize the Prescription Drug User Fee Act (“PDUFA”) through fiscal year 2012.  Earlier today, a “staff agreement” (427 pages) and summary of the legislation was …

    • D.C. District Court Denies Apotex Motion for Injunctive Relief in Generic PRILOSEC CaseSeptember 17th, 2007

      Earlier today, the U.S. District Court for the District of Columbia denied Apotex’s motion for a temporary restraining order and preliminary injunction in a case against FDA involving Apotex’s ANDA for a generic version of AstraZeneca’s PRILOSEC (omeprazole) Delayed-Release Capsules and the effects of AstraZeneca’s …

    • Court Finds D.C. Law Prohibiting Patented Drugs from Being Sold for an Excessive Price Preempted by Federal Patent LawAugust 27th, 2007

      On August 1, 2007, the U.S. Court of Appeals for the Federal Circuit affirmed (errata) the U.S. District Court for the District of Columbia’s December 2005 ruling declaring that the District of Columbia’s Prescription Drug Excessive Pricing Act of 2005 (the “Act”) is preempted by …

    • Is FDA Poised to Withdraw the First Subpart H Approval?August 9th, 2007

      In December 1992, FDA promulgated final regulations under which the Agency will accelerate the approval of certain new drugs and biologics for serious or life-threatening illnesses, and when such products provide a meaningful therapeutic benefit to patients over existing treatments. These regulations, which are commonly …

    • The “Dog Ate My Homework Act” ResurfacesAugust 2nd, 2007

      Legislation that would permit the U.S. Patent and Trademark Office (“PTO”) to exercise discretion to accept untimely filed Patent Term Extension (“PTE”) applications has reportedly been added to the “Patent Reform Act of 2007” (S. 1145) by Senator Edward Kennedy (D-MA).  Representative William Delahunt (D-MA), …

    • Support for BioGenerics Legislation Is Falling Apart at the SeamsJuly 23rd, 2007

      Support for legislation that would create a biogenerics approval path is reportedly crumbling.  Last month, the Senate Health, Education, Labor, and Pensions (“HELP”) Committee passed S. 1695, “the Biologics Price Competition and Innovation Act of 2007.”  Although neither the full Senate, nor the House Energy …

    • FDA is Asked for a Third Time About Orange Book Patent Listings for Drug Delivery SystemsJuly 12th, 2007

      For the third time in as many years, FDA has been requested to provide an advisory opinion on the Agency’s policy for the submission of patents for Orange Book listing that cover drug delivery systems (e.g., metered-dose and dry powder inhalers, and transdermal patches) that …

    • Orphan Drug Designation Not Sacrosanct – FDA Revokes Orphan Designation for TheraCLEC for EPI, but Other Exclusivity Issues RemainJuly 11th, 2007

      In a July 3, 2007 filing with the Securities and Exchange Commission (“SEC”), Altus Pharmaceuticals Inc. announced that the company was notified by FDA’s Office of Orphan Products Development (“OOPD”) that the orphan drug designation granted in January 2002 to ALTU-135, also know as TheraCLEC, …

    • Mylan Loses Again on Generic NORVASCJuly 9th, 2007

      On June 29, 2007, the U.S. District Court for the District of Columbia, in Mylan v. Leavitt, issued a memorandum opinion denying Mylan’s Emergency Motion for a Temporary Restraining Order that asked the court to order FDA to relist Pfizer’s U.S. Patent No. 4,879,303 covering …

    • BMS and Sanofi-Aventis Prevail over Apotex in Plavix Patent LitigationJune 20th, 2007

      Our “blogfather” over at the Orange Book Blog already has a preliminary post up about the recent victory in the district court by Bristol-Myers Squibb and Sanofi-Aventis over Apotex relating to the enforceability and validity of the patent on the active ingredient in Plavix.  Long …

    • FDARA: Single Enantiomer Exclusivity RevisitedJune 19th, 2007

      In chemistry, enantiomers are stereoisomers that are non-superimposable complete mirror images of one another.  Enantiomers may be either “right-handed” (dextro-rotary) S(+)-isomers, or “left-handed” (levo-rotary) R(-)-isomers.  A racemic mixture is one that has equal amounts of “left- and right-handed” enantiomers of a particular chiral molecule.  For …